Events

Recall of Device Recall Harmony LA/LED Arm Adapter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Steris Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    58107
  • Event Risk Class
    Class 2
  • Event Number
    Z-1886-2011
  • Event Initiated Date
    2011-02-18
  • Event Date Posted
    2011-04-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98365
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Light, surgnical, ceiling mounted - Product Code FSY
  • Reason
    The arm adapter does not contain labelling specifying the applicable weight and moment limitations of the arm adapter.
  • Action
    Steris Corporation sent an Urgent Field Correction Notice letter dated February 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Steris representative would contact customers to arrange for replacement of the product. For questions regarding the firms visit to their facility, customers were instructed to contact Steris Field Service Dispatch at 1-800-333-8828. For any questions regarding this matter call 440-392-7705.

Device

Device Recall Harmony LA/LED Arm Adapter
  • Model / Serial
    Model Number: LB61
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CO, IL, IN, MO, NC, NV, NY and OH and the countrries of Canada, China, and Australia.
  • Product Description
    Harmony LA/LED Monitor Arm Adapter. Model Number: LB61 || The Harmony LA/LED Monitor Arm Adapter is an accessory to the Harmony LA and LED Surgical Lighting System and is attached to the end of the monitor suspension arm to allow Customers to attach other medical devices, such as non-STERIS monitors, camera or other compatible items in place of the STERIS monitor. The Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible immunization of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The device is intended to be used by surgeons and other medical care practitioners in a surgical setting
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    USFDA